BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1082200 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01510
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 23, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 22, 2008 THE LAY USER/PT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH ULTRA 2 METER WAS READING INACCURATELY. THE PT THINKS THE METER HAS BEEN INACCURATE FOR SEVERAL WEEKS. ON THE DAY PRIOR AT 1:30 PM, THE PT TESTED HIS BLOOD GLUCOSE LEVEL AND REPORTEDLY OBTAINED A RESULT OF 219 MG/DL. DUE TO THIS RESULT HE ALLEGEDLY TOOK 25 UNITS OF BERLINSULIN 30/70. HE ALSO DECIDED TO TAKE AN ADD'L METFORMIN PILL. AT 4:30 PM THE PT WAS REPORTEDLY SWEATING. HE TESTED HIS BLOOD GLUCOSE LEVEL AT THAT TIME AND OBTAINED A RESULT OF 59 MG/DL. DUE TO THIS READING, HE REPORTEDLY TOOK SOME ORAL GLUCOSE. HE MENTIONED HE DID NOT FEEL WELL THE ENTIRE AFTERNOON. AT 11:45 PM, THE PT REPORTEDLY OBTAINED A RESULT OF 286 MG/DL AND AGAIN TOOK 25 UNITS OF BERLINSULIN 30/70. HE ALSO TOOK METFORMIN AT THIS TIME. THE MORNING BEFORE HE CALLED LIFESCAN AT 8 AM, HE OBTAINED A READING OF 163 MG/DL AND TOOK 25 UNITS OF BERLINSULIN. THE PT HAS HAD DIABETES FOR 12 YEARS. THE PT EXPLAINED HIS SLIDING SCALE AS FOLLOWS: WHEN HIS RESULT IS 120-160 MG/DL, HE TAKES 20 UNITS OF HIS BERLINSULIN, WHEN IT IS 161-200 MG/DL HE TAKES 25 UNITS, AND WHEN IT IS BETWEEN 201-250 MG/DL 30 UNITS. IT IS UNK HOW MUCH METFORMIN THE PT TAKES. HE TESTS HIS BLOOD SUGAR FOUR TIMES PER DAY TO ADJUST HIS BERLINSULIN. ON THE TROUBLESHOOTING TELEPHONE CALL THE PT PERFORMED THREE TESTS AND THE RESULTS HE REPORTED WERE "257, 195, AND 185 MG/DL" PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL CRITERIA, THE DIFFERENCE BETWEEN THESE RESULTS FALLS WITHIN THE EXPECTED VALUE OF <=20%. IT WAS DETERMINED THAT THE PT'S TESTING TECHNIQUE WAS CORRECT. THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE RESULTS WERE VERIFIED IN THE METER MEMORY. IT WAS FOUND THAT THE CALIBRATION CODE NUMBER ON THE PT'S METER DID NOT MATCH THE CODE ON THE TEST STRIP VIAL. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THE READINGS WERE INACCURATE, TOOK ADD'L INSULIN BASED ON A PARTICULAR READING, AND REPORTEDLY SUFFERED SYMPTOMS INDICATIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2826608

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R